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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ShuntCheck Test Pack consisting of a ShuntCheck Thermosensor, an Instant Cold Pack and a skin marker in a clamshell container
NEURODX DEVELOPMENT LLC
TP-1
In Commercial Distribution

  • 00865435000335 ()
  • 10865435000318 ()
TP-1

  • Heater/cooler system tester kit
Data Acquisition Unit (DAQ) - an electronic connector box which connects a Windows computer running ShuntCheck software to the ShuntCheck Thermosensor
NEURODX DEVELOPMENT LLC
DAQ-1
In Commercial Distribution

  • 00865435000328 ()
DAQ-1

  • Heater/cooler system tester kit
ShuntCheck software - Installed on Windows computer; guides user through test procedure, gathers and analyzes thermal data, presents results screen with Flow Confirmed or Flow Not Confirmed plus a time-temperature graph
NEURODX DEVELOPMENT LLC
SCIII SW
In Commercial Distribution

  • 00865435000311 ()
SCIII SW

  • Heater/cooler system tester kit
Red LED light for the treatment of wrinkles
PULSADERM LLC
RB2010
In Commercial Distribution

  • 00864918000374 ()


  • Blue/red/infrared phototherapy lamp
No Description
BOEKEL INDUSTRIES, INC.
301000
In Commercial Distribution

  • 00863626000201 ()


  • Cryopreserved blood/tissue thawing unit
No Description
Elixir M.D. Inc.
LED Light Therapy Device
In Commercial Distribution

  • 00860013019402 ()


  • Blue/red/infrared phototherapy lamp
LED light for the treatment of wrinkles
PULSADERM LLC
RB2015
In Commercial Distribution

  • 00858830007061 ()


  • Blue/red/infrared phototherapy lamp
4 mode full body panel
BIOPHOTAS, INC.
Series 2 DELUX XL C/US
In Commercial Distribution

  • 00850523007938 ()
CXL2-001

  • Blue/red/infrared phototherapy lamp
4 mode full body panel
BIOPHOTAS, INC.
Series 2 DELUX C/US
In Commercial Distribution

  • 00850523007891 ()
CDL2-001

  • Blue/red/infrared phototherapy lamp
2-mode large panel
BIOPHOTAS, INC.
Series 2 SKIN C/US
In Commercial Distribution

  • 00850523007808 ()
CSK2-001

  • Blue/red/infrared phototherapy lamp
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